Infectious Disease

Lefamulin a safe, effective alternative to moxifloxacin for unilobar, multilobar pneumonia

October 17, 2021

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File T, et al. New knowledge and approaches for the treatment of severe pneumonia and its complications. Presented at: CHEST annual conference; October 17-20, 2021 (virtual meeting).

Disclosure:
File was the investigator for the LEAP-1 study, for which his institution received a research grant. See the executive summary for the other authors’ relevant financial information.

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In a pooled analysis of the LEAP 1 and LEAP 2 studies, lefamulin was safe and its effectiveness was comparable to that of moxifloxacin in patients with unilobar and multilobar community-acquired bacterial pneumonia.

“Various studies have shown that pneumonia with multilobar infiltration is associated with several decreased clinical outcomes, including higher mortality.” Thomas M. Files, MD, MS, FCCP, said the chair of the infectious diseases division at Summa Health, Akron, Ohio, during a virtual presentation at CHEST’s annual meeting. “Lefamulin is the first pleuromutilin antibiotic approved for intravenous and oral use in adults with community-acquired bacterial pneumonia based on the results of two phase 3 non-inferiority studies compared to moxifloxacin.”

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To evaluate the efficacy and safety of lefamulin (Xenleta, Nabriva Therapeutics) in patients with community-acquired bacterial pneumonia who have or are at risk of severe pneumonia, the researchers analyzed pooled data from the LEAP 1 and LEAP 2 studies based on the Presence of unilobar vs. multilobar infiltrates.

In LEAP 1, 551 adults with PORT risk classes III to V were randomly assigned to IV lefamulin 150 mg every 12 hours for 5 to 7 days or moxifloxacin 400 mg every 24 hours for 7 days with an optional IV to oral switch. In LEAP 2, 738 adults with PORT risk classes II to IV were randomly assigned to oral lefamulin 600 mg every 12 hours for 5 days or moxifloxacin 400 mg every 24 hours for 7 days.

Thomas M. Files, MD, MS, FCCP

For the post-hoc pooled analysis, researchers rated efficacy outcomes based on the primary endpoints of early clinical response and the investigator’s assessment of clinical response in testing cure. Endpoints were assessed in all randomized patients with at least one parent pathogen.

Of the patients randomized to lefamulin or moxifloxacin, 69% had unilobar infiltrates and 31% had multilobar infiltrates.

Patients with multilobar pneumonia were more common than patients with unilobar pneumonia older than 65 years, had a PORT risk score of IV or V, and had a history of asthma, COPD, or smoking. Streptococcus pneumoniae was the most commonly identified baseline pathogen overall, File said.

Patients assigned lefamulin or moxifloxacin had high and similar success rates for early clinical response, File said. In patients with unilobar infiltrates, the early clinical response was 92% in the lefamulin group and 94% in the moxifloxacin group, and in those with multilobar infiltrates the rates were 85% and 90%, respectively.

The investigator’s assessment of clinical response was also similar. In patients with unilobar infiltrates, the rates were 86% in the lefamulin group and 89% in the moxifloxacin group, and in patients with multilobar infiltrates, the rates were 77% and 80%, respectively.

The most common treatment-related adverse reactions were gastrointestinal-related, and rates were similar in the lefamulin and moxifloxacin groups and in those with unilobar and multilobar infiltrates, File said.

“Based on the data shown here and elsewhere in outpatients and non-severe inpatients with community-acquired bacterial pneumonia, lefamulin as an alternative to fluoroquinolones would fit well into these treatment recommendations,” said File.

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CHEST annual meeting

CHEST annual meeting

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